FDA.reportPublic FDA data

Maxillary Seeker B

Primary DI
07540209955198
Brand
Maxillary Seeker B
Company
ClaroNav Kolahi Inc
Model
950-NE-MS-B
Device description
Maxillary Seeker B for Navient
Published
2025-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540209955198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540209955198075402099551987540209955198

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203466065
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540209955129Frontal Seeker950-NE-FS2025-05-27
07540209955136Maxillary Seeker950-NE-MS2025-05-27
07540209955143Bayonet Probe950-NE-BP2025-05-27
07540209955150Registration Probe950-NE-RP2025-05-27
07540209955167Tip Calibrator950-NE-TP2025-05-27
07540209955181Frontal Seeker B950-NE-FS-B2025-05-27
07540209955204Bayonet Probe950-NE-BP-B2025-05-27
07540209955211Registration probe B950-NE-RP-B2025-05-27
07540209955259Tip Calibrator B950-NE-TC-B2025-05-27
07540209955266Universal Tracker 1950-NE-UT12025-05-27
07540209955273Universal Tracker 2950-NE-UT22025-05-27
07540209955280Universal tracker 1 B950-NE-UT1-B2025-05-27
07540209955297Universal Tracker 2 B95-NE-UT2-B950-NE-UT2-B2025-05-27
07540209955716Patient Tracker955-NE-PT2025-05-27
07540209956300C-Clamp small950-NE-UTCS2025-05-27
07540209956317C-Clamp medium950-NE-UTCM2025-05-27
07540209956324C-Clamp Large950-NE-UTCL2025-05-27
07540209956331C-Clamp XL950-NE-UTCXL2025-05-27
07540209956348ENT Sterilization Tray950-NE-STE2025-05-27
07540209955501Navient System with kits955-NC-NC2025-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720892330826Ball Joint Guide Array (BJGA)-Navigation SetBayer Medical Care B.V.HAW2026-04-24
08720892330833Ball Joint Guide Array (BJGA)-Guide SetBayer Medical Care B.V.HAW2026-04-24
10381780542278CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
10381780542285CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
10381780542292Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-03
G076A012354A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
G076A012355A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
07613327499711N/AStryker Leibinger GmbH & Co. KGHAW2023-03-23
07613327500516N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500561N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500578N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327503265N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
10603295522850VELYSDEPUY (IRELAND)HAW2021-07-30
07613327413076n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413090n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413205n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
10603295493624SIGMADEPUY ORTHOPAEDICS, INC.HAW2018-04-19
10650551098277PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2018-01-28
10381780167334CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252252CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252351Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252368Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252375CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252382Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252399Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252405CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252412CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252429CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252436Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252443Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14